Glucose Measuring Device for Use in Personal Area Network

ABSTRACT

A glucose measuring system includes a glucose meter that incorporates wireless communication capabilities. The meter can advantageously be a low cost meter by eliminating expensive components, such as the display. The user nevertheless is able to retrieve and view his or her glucose values by referring to displays within the glucose measuring local area network. Feedback via these displays can advantageously be used by the diabetic to create a higher level of confidence and safety.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/426,887 filed Apr. 20, 2009, now U.S. Pat. No. 8,647,269, which is acontinuation of U.S. patent application Ser. No. 10/861,625 filed onJun. 4, 2004, now U.S. Pat. No. 8,066,639, entitled “Glucose MeasuringDevice For Use In Personal Area Network”, which claims priority to U.S.Provisional Patent Application No. 60/477,730 filed on Jun. 10, 2003,entitled “Glucose Measuring Device For Use In Personal Area Network”,the disclosures of each of which are incorporated herein by referencefor all purposes.

FIELD OF THE INVENTION

This invention relates to a device and method for determining andreporting glucose readings in wireless personal area networks fordiabetics.

BACKGROUND

The number of diagnosed cases of diabetes continues to increase in theU.S. and throughout the world, creating enormous economic and publichealth consequences. Devices and therapies that improve the quality oflife for the diabetic patient thus are important not only for thepatient, but for society at large. One area in which recently developedtechnologies have been able to improve the standard of care has been inthe maintenance of tight control over the blood glucose levels. It iswell known that if a diabetic patient's blood glucose values can bemaintained in a relatively narrow and normal range of from about 80milligrams per deciliter (mg/dL) to about 120 mg/dL, the physiologicallydamaging consequences of unchecked diabetes can be minimized. Withbetter blood glucose information, diabetic patients can better exercisetight control of their blood glucose level through a variety of means,including diet, exercise, and medication. For this reason a largeindustry has developed to provide the diabetic population with ever moreconvenient and accurate ways to measure blood glucose. There are manyforms of these measuring devices; one common type is represented byhand-held electronic meters which receive blood samples via enzyme-based“test strips”. In using these systems, the patient lances a finger oralternate body site to obtain a blood sample, the strip is inserted intoa test strip opening in the meter housing, the sample is applied to thetest strip and the electronics in the meter convert a current generatedby the enzymatic reaction in the test strip to a blood glucose value.The result is displayed on the (typically) liquid crystal display of themeter. Usually, this display must be large so that diabetics who oftenhave deteriorating vision, can more easily see the result.

It is known that such hand-held meters can advantageously bemanufactured to include wireless communication capability. Suchcapability can assist the user in downloading data to a home computer orto a handheld computing device, for example. This minimizes the need forthe user to write down data and transfer it later to an electronicrecord.

It is also known that hand-held meters are often given to users, so thatsuppliers of the strips used with the meters can generate greater stripsales. This makes the cost of the hand-held meters critical toprofitability of the manufacturers. If the cost of a meter is relativelyhigh, profits from the sale of strips will be small or worse yet,non-existent. If the cost of the meter can be reduced, profitability isimproved.

Lastly, it is well known that if a strip and meter system is convenientto use, patients will test more often and compliance with treatmentprograms will improve. Including wireless communication in the meteradds convenience, but at a cost. For these reasons, there is acontinuing need for a low cost meter and strip glucose monitoring systemthat nevertheless has highly convenient features, including wirelesscommunication capabilities.

SUMMARY

The present invention is a glucose monitoring system which includes aglucose meter system of the meter and strip type that includes wirelesscommunication capabilities. The system can be a reduced cost systemhowever, by eliminating components from the meter, such as therelatively large LCD display, and instead relying on such components inother electronic devices that now typically surround a patient almostevery day and can form part of the monitoring system. By eliminatinghigh cost components from the meter but retaining the wirelesscommunication functionality, the meter portion of the system can berelatively low cost, yet the system overall provides highly convenientfeatures to the user.

Accordingly, in one embodiment of the present invention, there isprovided a data communication system including a data network, a clientunit operatively coupled to the data network, and a server unitoperatively coupled to the data network for communicating with theclient unit, said server unit further configured to receive bloodglucose related data from the client unit over the data network.

The client unit may be configured to encrypt the blood glucose relateddata for wireless transmission over the data network to the server unit.Moreover, the client unit may include a blood glucose meter.

In an alternate embodiment, the data communication over the data networkmay include one of an 802.11 protocol, a Bluetooth® protocol, a radiofrequency (RF) protocol, and an Infrared Data Association (IrDA)protocol.

Furthermore, the server unit may in one embodiment include a display.

The system in accordance with yet another embodiment may include a baseunit configured to communicate with the server unit over the datanetwork, the base unit configured to store data received from the serverunit, and further, the base unit configured to provide an insulin pumpprotocol to said server unit.

The data network may include a personal area network, where the personalarea network is configured for short range wireless communication.

In a further embodiment, the client unit may be configured with passwordprotection.

Additionally, the client unit may include one or more of a compacthandheld device, a personal digital assistant, and a mobile telephone.

In accordance with another embodiment of the present invention, there isprovided a method of providing a data communication system including thesteps of establishing a data network, operatively coupling a client unitto the data network, and operatively coupling a server unit to the datanetwork to communicate with the client unit, the server unit furtherconfigured to receive blood glucose related data from the client unitover the data network.

The method may further include the step of encrypting the blood glucoserelated data for wireless transmission over the data network.

Moreover, the step of establishing the data network may include the stepof implementing one of an 802.11 protocol, a Bluetooth® protocol, an RFprotocol, and an IrDA protocol.

Also, the method in a further embodiment may include the step ofdisplaying the data received from the client unit.

Moreover, in another embodiment, the method may include the step ofconfiguring a base unit to communicate with the server unit over thedata network, the step further including storing data received from theserver unit. Also, the step of configuring the base unit further mayinclude the step of providing an insulin pump protocol to said serverunit. Moreover, the method may also include configuring the personalarea network for short range wireless communication.

Additionally, the method may include the step of password protectingaccess to the client unit.

In accordance with yet another embodiment of the present invention,there is provided a personal area network, a blood glucose meteroperatively coupled to the personal area network, and a server unitoperatively coupled to the personal area network for wirelesslycommunicating with the meter, said server unit further configured toreceive blood glucose data from the meter over the personal areanetwork.

The invention will now be described by reference to the figures, whereinlike reference numerals and names indicate corresponding structurethroughout the several views.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view showing typical data signal flow betweendevices of a wireless system constructed according to one embodiment ofthe present invention.

FIG. 2 is a schematic view showing the client device of FIG. 1.

FIG. 3 is a schematic view showing the server device of FIG. 1.

FIG. 4 is a pictoral view showing a typical client device and typicalserver devices.

FIG. 5 is a perspective view showing an integrated device of analternative embodiment.

DETAILED DESCRIPTION

Referring to FIG. 1, a wireless system constructed according to apreferred embodiment of the present invention will be described. Teststrip 101 electrically communicates with client device 102, whichwirelessly communicates with server device 104, such as by two-way radiofrequency (RF) contact, infrared (IR) contact, Bluetooth® contact orother known wireless means 103. Optionally, server device 104 can alsocommunicate with other devices such as data processing terminal 105 bydirect electronic contact, via RF, IR, Bluetooth® or other wirelessmeans.

Test strip 101 is a commonly known electrochemical analyte test strip,such as a blood glucose test strip as described in U.S. patentapplication Ser. No. 09/434,026 filed Nov. 4, 1999 entitled “SmallVolume In Vitro Analyte Sensor and Methods”, incorporated herein byreference. It is mechanically received in a test strip port of a clientdevice 102, similar to a commonly known hand-held blood glucose meter asdescribed in the aforementioned patent application. In the preferredembodiment, client device 102 is constructed without a user interface ordisplay to keep the size and cost of device 102 to a minimum. Clientdevice 102 can take the form of a highlighter or easel-sized pen, asshown in FIG. 4, and can be powered by a single AA or AAA size battery.

Client device 102 wirelessly communicates with server device 104,preferably using a common standard such as 802.11, Bluetooth®, wirelessprotocol, or an IrDA infrared protocol. Server device 104 can be anotherportable device, such as a Personal Digital Assistant (PDA) or notebookcomputer, or a larger device such as a desktop computer, appliance, etc.as shown by the examples in FIG. 4. Preferably, server device 104 doeshave a display, such as a liquid crystal display (LCD), as well as aninput device, such as buttons, a keyboard, mouse or touch-screen. Withthis arrangement, the user can control client device 102 indirectly byinteracting with the user interface(s) of server device 104, which inturn interacts with client device 102 across wireless link 103.

Server device 104 can also communicate with another device 105, such asfor sending glucose data from devices 102 and 104 to data storage indevice 105, and/or receiving instructions or an insulin pump protocolfrom a health care provider computer 105. Examples of such communicationinclude a PDA 104 synching data with a personal computer (PC) 105, amobile phone 104 communicating over a cellular network with a computer105 at the other end, or a household appliance 104 communicating with acomputer system 105 at a physician's office.

Referring to FIG. 2, internal components of the client device 102 suchas a blood glucose meter of the preferred embodiment are shown. Asshown, the client device 102 includes an analog interface 201 configuredto communicate with the test strip 101 (FIG. 1), a user input 202, and atemperature detection section 203, each of which is operatively coupledto a processor 204 such as a central processing unit (CPU). Furthershown in FIG. 2 are a serial communication section 205 and an RFtransmitter 206, each of which is also operatively coupled to the clientdevice processor 204. Moreover, a power supply 207 is also provided inthe client device 102 to provide the necessary power for the clientdevice 102. Additionally, as can be seen from the Figure, a clock 208 isprovided to, among others, supply real time information to the clientdevice processor 204.

Alternatively, user input 202, such as push button(s), and othersections can be eliminated to reduce size and cost of client device 102.The glucose meter housing may contain any glucose sensing system of thetype well known in the art that can be configured to fit into a smallprofile. Such a system can include, for example, the electrochemicalglucose strip and meter sensing system sold by Abbott Diabetes Care Inc.of Alameda, Calif. under the Freestyle® brand, or other strip and meterglucose measuring systems. The housing may thus encompass the sensorelectronics and a strip connector, which connector is accessed via atest strip port opening in the housing. The housing will typically alsoinclude a battery or batteries.

Referring to FIG. 3, internal components of a server device 104 of thepreferred embodiment are shown. Referring to FIG. 3, the server device104 includes a blood glucose test strip interface 301, an RF receiver302, an input unit 303, a temperature detection section 304, and a clock305, each of which is operatively coupled to a server device processor307. As can be further seen from the Figure, the server device 104 alsoincludes a power supply 306 operatively coupled to a power conversionand monitoring section 308. Further, the power conversion and monitoringsection 308 is also coupled to the server device processor 307.Moreover, also shown are a receiver serial communication section 309,and an output 310, each operatively coupled to the server deviceprocessor 307.

Note that a redundant test strip interface 301 can be provided ifdesired for receiving test strips 101 (FIG. 1). Device 104 can be aproprietary unit designed specifically for use with blood glucosemeters, or can be a generic, multipurpose device such as a standard PDA.An example of a similar device designed for blood glucose testing isdisclosed in U.S. Pat. No. 6,560,471 issued May 6, 2003 entitled“Analyte Monitoring Device and Methods of Use”, incorporated herein byreference.

FIG. 4 shows examples of the devices to and from which the meter of theinvention can communicate. Such devices will become part of anindividual's personal area network and each becomes enabled with shortrange wireless communication capabilities. Desktop, laptop and handheldcomputers, as well as printers can be so enabled and will providedisplays and printouts valuable as records for the diabetic. Telephoneswill also be enabled in this fashion and can be used for displayingglucose data as well as further transmitting the data over largernetworks. Many of these devices can assist the diabetic by responding toglucose levels by providing alarms, or suggesting that action be takento correct a hypo or hyperglycemic condition, or to call necessarymedical assistance. Diabetics are aware of the risks involved in drivingwhen glucose levels are out of range and particularly when they are toolow. Thus, the navigation computer in the diabetic's car may become partof the local area network and will download glucose data from the meterwhen the diabetic enters the car. For safety sake, the car computersystem may be programmed to require that the diabetic perform a glucosetest before driving, and more specifically the car may be disabledunless the diabetic takes the test and the result is in an appropriaterange.

The pen shaped client device 102 shown in FIG. 4 preferably has a teststrip port 201 (not shown in FIG. 4) located on its distal end. Becausethe sensitive analog “front end” circuitry associated with measuring thevery small electrochemistry currents from test strips 101 is locatedadjacent to strip port 201, it is advisable to not design a wirelesslink antenna too close to this distal end as it may interfere with theproper operation of the glucose sensing circuitry. On the other hand, ifthe wireless link antenna is located at the proximal end of the clientdevice 102, it will likely be covered by the hand of the user holdingit, which may limit the range of the low transmission power device to anunacceptable distance. Accordingly, it is preferable to design thelayout of client device 102 such that an internal antenna is located ina middle section of the device away from the distal and proximal ends.

Referring to FIG. 5, an alternative embodiment of the present inventionis shown. Due to the reduced size of a blood glucose meter 102 when itdoes not include a display or push buttons, it can be combined with alancing device to form an integrated unit 102′. Test strip port 201 canbe located in the side of integrated device 102′ or wherever there isroom available. A test strip storage compartment can also be locatedwithin integrated device 102′ and accessed through a flip-lid 220 orother suitable closure means. If room permits, a second test stripstorage compartment (not shown) can be included so that fresh strips andused strips can be separately stored. Preferably, a desiccant isprovided in one of the storage compartments to preserve the freshstrips. The design and use of lancing devices is described in U.S. Pat.No. 6,283,982 issued on Sep. 4, 2001 entitled “Lancing Device and Methodof Sample Collection”, incorporated herein by reference. By integratingthese features together in a single device without a user interface, thetypical test kit that is carried around by people with diabetes can bemade much smaller, easier to handle, and less costly.

Thus, one of the important features of the invention is reliance of the“displayless” glucose meter unit on a separate display device in orderto minimize the complexity and cost of the meter unit. This permits theuser to use the larger display units within his or her personal areanetwork, all of which can be synchronized as they interact andcommunicate with the wireless enabled meter. When the meter is used, thesequences through which the user must “step” to complete the test arereadily viewed on the larger display units (e.g. entering thecalibration code, prompting application of the sample). At the same timethe meter unit is simplified, smaller and less expensive to manufacture.Additionally, control buttons that are found on typical glucose meterscan be eliminated, saving additional size and cost, since the user canrely on the user in out features of the server device instead. It isexpected that the simplified, wireless enabled meters of the inventionmay ultimately become inexpensive enough to make them disposable after aspecified number of uses, permitting the producer to routinely upgradeas appropriate.

Additionally, the system permits the user to include security coding atany time the meter unit accesses a display device, so that the user'sdata is secure. That is, it is considered an important feature of theinvention that when the “client” meter of the invention is used, thatthe system will require the user to enter an identity code in order toverify that the person handling the meter is indeed an authorized user.Of course, it is possible for the system to permit more than one user ifthe meter owner so desires. Moreover, the user's data may optionally beencrypted prior to wireless transmission and thereafter respectivelydecrypted upon wireless reception.

While the module need not include a large or expensive display, it maynevertheless be advantageous to include some ability to advise the userof a glucose level which is determined when the module is used as a“stand-alone” unit. For example, the module could include a very lowcost, small three digit LCD display. Alternatively, the module couldinclude LED indicator lights (e.g. red for out of desired range, greenfor within desired range). Other possibilities include a red LED forbelow range, a green LED for within range, and a yellow LED for aboverange, or a column of LEDs or an electroluminescent strip (similar tothose used on common batteries to indicate battery life) to indicateapproximate or relative glucose levels.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

What is claimed is:
 1. A data communication system, comprising: a clientunit including a client wireless communication module and a glucosesensor in contact with a bodily fluid to determine a glucose level inthe bodily fluid and generate corresponding glucose data, the bodilyfluid comprising one of blood or interstitial fluid; and an automobileincluding an automobile communication module configured to communicatewith the client unit to receive the glucose data from the client unit;wherein the automobile comprises programming that includes one or moreacceptable glucose level ranges, and wherein one or more functions ofthe automobile is configured to be disabled until the received glucosedata is within the one or more acceptable glucose level ranges.
 2. Thesystem of claim 1, wherein the client unit is configured to encrypt theglucose data.
 3. The system of claim 2, wherein the automobile isconfigured to decrypt the glucose data.
 4. The system of claim 1,wherein the communication between the client unit and the automobile isbased on an 802.11 protocol, a short-range wireless communicationprotocol, a radio frequency (RF) protocol, an infrared data association(IrDA) protocol, or one or more combinations thereof.
 5. The system ofclaim 1, wherein the automobile is configured to generate one or morehealth management signals based on the glucose data received from theclient unit.
 6. The system of claim 1, wherein the automobile comprisesan alarm that is configured to activate based on the received glucosedata.
 7. The system of claim 6, wherein the alarm comprises one or moreof an audio alert, a graphical display or a vibratory alert.
 8. Thesystem of claim 1, wherein the automobile is configured to provide asuggested action to be taken based on the received glucose data.
 9. Thesystem of claim 1, wherein the automobile is configured to requestassistance based on the received glucose data.
 10. The system of claim1, wherein the automobile programming is configured to request theglucose data from the client unit.
 11. The system of claim 10, whereinthe automobile programming is configured to disable one or morefunctions of the automobile until the glucose data is received.
 12. Thesystem of claim 1, wherein the automobile comprises an interface toreceive one or more blood glucose test strips.
 13. The system of claim1, further including a security code unit including one or more userauthorization codes stored in a memory.
 14. The system of claim 1,wherein the client unit is one of a handheld device, a personal digitalassistant or a mobile telephone.
 15. The system of claim 1, wherein theautomobile is configured to automatically download the glucose data fromthe client unit when the client unit is located in the automobile. 16.The system of claim 1, wherein glucose information related to theglucose data is conveyed through an audio system of the automobile. 17.A data communication system, comprising: a glucose sensor in contactwith a bodily fluid and configured to generate one or more signalsassociated with a monitored glucose level in the bodily fluid includingone of blood or interstitial fluid; a client unit in signalcommunication with the glucose sensor and configured to process the oneor more signals associated with the monitored glucose level from theglucose sensor to generate glucose data; and an automobile configured tocommunicate with the client unit to receive the glucose data from theclient unit; wherein the automobile comprises programming where one ormore functions of the automobile is configured to be disabled until thereceived glucose data is within one or more acceptable glucose levelranges.
 18. The system of claim 17, wherein the client unit is one of ahandheld device, a personal digital assistant or a mobile telephone. 19.The system of claim 17, wherein the automobile is configured toautomatically download the glucose data from the client unit when theclient unit is located in the automobile.
 20. The system of claim 17,wherein the communication between the client unit and the automobile isbased on an 802.11 protocol, a short-range wireless communicationprotocol, a radio frequency (RF) protocol, an infrared data association(IrDA) protocol, or one or more combinations thereof.